Biological material pre-fixation treatment
First Claim
1. A bioprosthetic heart valve, comprising:
- at least one leaflet that is adapted for reciprocal motion from an open position to a closed position upon blood flow through the valve;
the at least one leaflet being formed, at least in part, of biological material that has been subjected to controlled autolysis, wherein the biological material that is subjected to controlled autolysis has structural integrity and comprises cells and non-cellular structural components, and wherein the controlled autolysis comprises exposing the biological material, prior to any fixation thereof, to at least one buffered solution having a pH in the range from about 5.0 to 8.0 and a temperature in the range from about 12°
C. to 30°
C. for a sufficient period of time to facilitate degradation of cells by autolytic enzymes within the cells so as to render at least one region of the biological material substantially acellular while substantially preserving the structural integrity and non-cellular structural components of the biological material.
2 Assignments
0 Petitions
Accused Products
Abstract
Disclosed is a controlled autolysis method for making biological tissue substantially acellular by exposing the biological material, prior to any fixation thereof, to at least one buffered solution having a pH in the range from about 5.0 to 8.0 and a temperature in the range from about 12° C. to 30° C. for a sufficient period of time to render at least one region of the biological material substantially acellular while substantially preserving the structural integrity and non-cellular structural components of the biological material. Also disclosed is a method of making a bioprosthetic heart valve using biological material that has been treated by controlled autolysis and a method of treating a mammal having a defective heart valve using a bioprosthetic heart valve made, in part, by controlled autolysis.
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Citations
14 Claims
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1. A bioprosthetic heart valve, comprising:
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at least one leaflet that is adapted for reciprocal motion from an open position to a closed position upon blood flow through the valve; the at least one leaflet being formed, at least in part, of biological material that has been subjected to controlled autolysis, wherein the biological material that is subjected to controlled autolysis has structural integrity and comprises cells and non-cellular structural components, and wherein the controlled autolysis comprises exposing the biological material, prior to any fixation thereof, to at least one buffered solution having a pH in the range from about 5.0 to 8.0 and a temperature in the range from about 12°
C. to 30°
C. for a sufficient period of time to facilitate degradation of cells by autolytic enzymes within the cells so as to render at least one region of the biological material substantially acellular while substantially preserving the structural integrity and non-cellular structural components of the biological material. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
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14. A bioprosthetic heart valve, comprising:
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at least one leaflet that is adapted for reciprocal motion from an open position to a closed position upon blood flow through the valve; the at least one leaflet being formed, at least in part, of biological material that has been subjected to controlled autolysis, wherein the biological material that is subjected to controlled autolysis has structural integrity and comprises cells and non-cellular structural components, and wherein the controlled autolysis consists essentially of exposing the biological material, prior to any fixation thereof, to at least one solution consisting essentially of a buffer having a pH in the range from about 5.0 to 8.0 and a temperature in the range from about 12°
C. to 30°
C. for a sufficient period of time to facilitate degradation of cells by autolytic enzymes within the cells so as to render at least one region of the biological material substantially acellular while substantially preserving the structural integrity and non-cellular structural components of the biological material.
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Specification